Cleared Traditional

K884598 - SHIMADZU DIGITAL SUBTRACTION SYSTEM DAR...

K884598 is an FDA 510(k) clearance for SHIMADZU DIGITAL SUBTRACTION SYSTEM DAR..., manufactured by Shimadzu Precision Instruments, Inc.. The device is a Class 2 Radiology device with product code JAA cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K884598 · Shimadzu Precision Instruments, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1989
Decision
168d
Days
Class 2
Risk

K884598 is an FDA 510(k) clearance for the SHIMADZU DIGITAL SUBTRACTION SYSTEM DAR-1200. Classified as System, X-ray, Fluoroscopic, Image-intensified (product code JAA), Class II - Special Controls.

Submitted by Shimadzu Precision Instruments, Inc. (Torrance, US). The FDA issued a Cleared decision on April 20, 1989 after a review of 168 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1650 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Shimadzu Precision Instruments, Inc. devices

FDA 510(k) Submission Details - K884598

510(k) Number K884598 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1988
Decision Date April 20, 1989
Days to Decision 168 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d slower than avg
Panel avg: 107d · This submission: 168d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAA Device Classification - Class 2, Special Controls

Product Code JAA System, X-ray, Fluoroscopic, Image-intensified
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1650
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - JAA System, X-ray, Fluoroscopic, Image-intensified

All 149
Devices cleared under the same product code (JAA) and FDA review panel - the closest regulatory comparables to K884598.
X-RAY EQUIPMENT (VARIOUS TYPES)
K895730 · Continental X-Ray Corp. · Nov 1989
DA-100HS
K894913 · Fischer Imaging Corp. · Sep 1989
DIGITAL SPOT IMAGING (DSI)
K893131 · Philips Medical Systems, Inc. · Jun 1989
UNIVERSAL ABC CONTROLER
K883580 · Philips Medical Systems (Cleveland), Inc. · Jan 1989
MEDRAD FLUOROSCOPIC VIDEO ENHANCEMENT SYSTEM
K884317 · Medrad, Inc. · Dec 1988
ALPHA MC-9S MOBIL C-ARM IMAGE INTENSIFIER UNIT
K883372 · Ausonics Pty , Ltd. · Nov 1988